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Observational Study on Cognitive Impairment in Colorectal Cancer Patients Receiving Chemotherapy

This research study at Parkview Cancer Institute is looking at how the brain changes in people receiving chemotherapy (cytotoxic drug) for colon or rectal cancer. The goal is to find better ways to identify individuals who might have difficulties with thinking and memory due to their cancer treatments. This is an observational study, meaning researchers will be watching and collecting information without giving a specific intervention. The study aims to enroll 60 participants aged 18 and older. Success will be measured by surveys and analyzing specific proteins (cytokines) in the body after 7 years. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 60 participants. It is not specified if it's randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 7 years, with surveys and protein analysis at that time point.

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NCT05014399

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Recruiting
Not specifiedAges 18+Observational
Joseph McCollom
~60 participants
Updated 2026-08-14 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survey
Measured over 7 Years
+1 more outcome measured

Conditions

Neoplasm, Colorectal
Cognitive Impairment
Cognitive Dysfunction
Cognitive Change
Chemo-brain
Chemo Fog
Chemotherapy Effect
Cognitive Decline

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Joseph McCollom, DO · PRINCIPAL_INVESTIGATOR · Parkview Health

Who to contact

Joseph McCollom, DO
[email protected]
260-266-7100
Email the study team

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Eligibility criteria

Inclusion

Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.
A histologically-confirmed colorectal tumor
Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.
Patients must not have received cytotoxic chemotherapy previous to enrollment.

Exclusion

Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
Pregnant or breastfeeding
Any known brain metastases
Non-English speaking patients
Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.
Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.

What this trial measures

  • Survey7 Years

    FACT-Cog V3

  • The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b)7 years

    This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.